EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles
FDA inspection history in Andrimont, Belgium, 2015 to 2025
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one warning letter; 2023: two Form 483s; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter.
- 2023–25Three Form 483s, at Andrimont, Belgium.
- 2025The longest 483 on file: 5 observations over 5 pages at Andrimont, Belgium.
Cited most
Across all EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles observations on file
- 21 CFR 803.18(a)What are the requirements for establishing and maintaining MDR files or records that apply to me?2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.70(a)Production and process controls2
- 21 CFR 820.80(a)Receiving, in-process, and finished device acceptance2
- 21 CFR 830.300Devices subject to device identification data submission requirements2
The complete EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Andrimont, Belgium
Two Form 483s · 2023 to 2025 · 6 observations
Latest: Form 483, Jul 31, 2025 →
Also: two documents not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-31 | 483 Form 483 | Andrimont, Belgium | 5 | $99 |
| 2023-03-02 | 483 Form 483 | — | 5 | $99 |
| 2023-03-02 | 483 Form 483 | Andrimont, Belgium | 1 | $99 |
| 2015-06-22 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3007697975 · most recent document Jul 31, 2025
About EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles
How many FDA Form 483s has EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles received?
FDA Intel has 3 Form 483s on file for EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles; the most recent is dated Jul 31, 2025.
When was EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles last inspected by FDA?
The most recent FDA inspection document on file for EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles is a Form 483 dated Jul 31, 2025, for the site in Andrimont, Belgium.
What did FDA cite at EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles?
The regulations cited most in the observations on file for EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles are 21 CFR 803.18(a) (What are the requirements for establishing and maintaining MDR files or records that apply to me?), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.70(a) (Production and process controls), 2 times.
Has EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles; the most recent is dated Jun 22, 2015.